Frequently Asked Questions on Key Points of Disinfection and Antibacterial Products Compliance in China

On April 12, Personal and Home Care Products Division and Agrochemicals Division in CIRS together held a free training course on the key points of disinfection products, antibacterial products and mosquito repellent products compliance in China. More than 600 people participated in this training course. CIRS Personal and Home Care Products Division has collected questions about disinfection and antibacterial products and shared as follows:

Q1: What is the production qualification and filing requirements for disinfection products?

CIRS: To produce domestic disinfection products, enterprises need to obtain the hygiene license for the production enterprises of disinfection products, and meet the requirements under Technical Requirements for the Hygiene and Safety Evaluation of Disinfection Products. There is no mandatory requirement for imported disinfection products. But some local health commissions may require GMP.

Q2: Can a disinfection product claim to kill or inhibit Coronavirus?

CIRS: As far as we know, the current test method for inactivating or suppressing Coronavirus has not yet passed the Metrology certification of China, that is, there is no CMA qualification seal on the test report. In this case, it is necessary to check with the experts in local health commissions on whether it can be declared on the label.

Q3: Do disinfection products have to be filed?

CIRS: According to the WS 628-2018 Technical Requirements for the Hygiene and Safety Evaluation of Disinfection Products, 4.1 The product liability unit shall conduct health and safety evaluation for Category 1 and Category 2 disinfection products before the first marketing and formulate a health and safety evaluation report. The product liability unit shall be responsible for the evaluation results. It can be known that Category 1 and Category 2 disinfection products need to be filed before selling; Other disinfection products such as wipes and sanitary wipes are currently not required to be filed.

Q4: What is the test basis for the Category 3 disinfection products?

CIRS: Based on specific products. Take sanitary wipes as an example: The test items can refer to GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, GB/T 27728-2011 Sanitary Wipes, WS 575-2017 Sanitary Requirements for Sanitary Wipes, etc

Q5: One detergent claims to have antibacterial and bacteriostatic effects. Is this detergent still categorized as disinfectants?

CIRS: Antibacterial agents must get in direct contact with human skin or mucous membrane while detergents not. The claim about antibacterial effects does not meet the requirements for disinfectants as well. A disinfection product must kill more than 99.999% of bacteria and fungi. As a result, even if detergent claims to have antibacterial and bacteriostatic effects, it does not belong to disinfectants.

Q6: How long is filing of disinfection products valid?

CIRS: The validity period for Category 1 disinfection products is 4 years; Category 2 disinfection products only need to be filed for one time and the filing will be long effective.

Q7: Are antibacterial hand sanitizers categorized as Category 2 antibacterial agents?

CIRS: If the active ingredients in the antibacterial hand sanitizers are categorized as disinfection products and the product is used in the way disinfection products are used, then the antibacterial hand sanitizer belongs to antibacterial agents, which is Category 2 disinfection products.

Q8: I need to paste the promotional information which I did not submit in the process of filing on the products for sales purposes. Does it violate the filing requirements?

CIRS: Theoretically, it is not ok. The product information submitted for filing should be consistent with the information used in the marketing process. You need to update the information for filing if there is any inconsistency and promote your products with the updated information after getting approved.

Q9: What does a toxicology test involves?

CIRS: Generally,  toxicology tests include acute oral toxicity test, acute inhalation toxicity test, skin irritation test, eye irritation test, vaginal mucosa irritation test, one mutagenic test, etc. Determine which tests need to be done based on the specific products and the regulatory requirements..

Q10: Is disinfection wipe categorized as disinfection products?

CIRS: According to the Catalogues of Disinfection Products, the disinfection wipes do not belong to the disinfection products, nor do they fall under the supervision of the Health Commission.

Q11: I have to entrust a third party to produce the disinfection products. Who shall do the filing, the entrusting party or the producer?

CIRS: Domestic disinfection products, if there is commissioned processing, should apply for filing in the name of the entrusting party.

Q12: When the disinfection products are transferred to another factory, do I need to apply for filing for a second time or do I just need to update the filing?

CIRS: According to 4.6 of WS 628-2018 Technical Requirements for the Hygiene and Safety Evaluation of Disinfection Products, if there is actual production address migration, new factory or workshop setting, or entrusted production and processing, the responsible units should complete several tests including the effective components content determination, the stability test for the original solution, the determination of pH value, and update the evaluation data.

Q13: Is there an expiry date for the third-party test report for the filing?

CIRS: At present, there is no mandatory requirements for the validity period of the test report, but it is recommended to apply for filing as soon as possible, in case there is a need for retesting, there is a risk that the product will be expired, or the national standard and test basis are changed.

Q14: How long does it take to process filing of bacteriostatic agents?

CIRS: Test period: about 4 and a half months for products with a two-year validity period, and about 3 months for products with a one-year validity period;

After all the filing material is submitted, it generally takes more than 1 month to review. There might be an advance or delay, different provinces and cities are not the same.

Q15: The validity period of the Health and Safety Evaluation Report for the Category 1 disinfection products is 4 years. On which date to calculate?

CIRS: Based on the filing date. Enterprises are suggested to complete the update of filing before the expiration of the 4-year period. (Some local health commissions require re-filing, related enterprises need to consult local health commissions if they need to get more detailed information).

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